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01 1Mallinckrodt Pharmaceuticals

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PharmaCompass

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BePharma
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Looking for Drug Master Files (DMF) for 29350 of Specgx Llc

Looking for Drug Master Files (DMF) for 29350 of Specgx Llc 1

20

Specgx Llc, based in Ireland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is METHADONE HYDROCHLORIDE USP, with a corresponding US DMF Number 29350.

Remarkably, this DMF maintains an Active status since its submission on September 29, 2015, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 09, 2016, and payment made on November 02, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II